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null New regulation and guideline for labelling and packaging leaflets for medicinal products

New regulation and guideline for labelling and packaging leaflets for medicinal products

22.10.2010

New regulation and guideline for labelling and packaging leaflets for medicinal products

The regulation and guideline for labelling and packaging leaflets for medicinal products have been amended. Regulation 1/2010 and guideline 1/2010 of the Finnish Medicine's Agency come into force on 30 October 2010, thereby repealing regulation 5/2005 of the National Agency for Medicine and guideline 2/2005 of the National Agency for Medicine previously issued on the matter.

The contents of the regulation and guideline have been checked and updated taking into account, among other things, changes in the EMA guidelines. Paragraphs relating to dose-dispensing packaging have been added to the provisions.

Read more:

Regulation (pdf)

Guideline (pdf)

Further information:

Teija Laakso, Special Researcher, tel. +358 9 4733 4251

E-mail address format firstname.lastname@fimea.fi.